Technical Engineer - Process Simulation

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations.
• Design/Author/Review/Approve/Execute process simulation qualification/validation documentation and studies in line with the standard approval process
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation
• Execution/development of change controls to support the Process Simulation process
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
• Implement subsequent corrective action through the change management system.
• Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations.
• Participate and/or lead cross functional or single function teams including liaising with vendors
• or above site groups.

• Report, standards, policy writing skills required
• Equipment and process validation
• Sterile filling processes and equipment
• Proficiency in Microsoft Office and job related computer applications required
• Lean Six Sigma Methodology experience desired